Abstract

The Tissue Culture Agar Overlay Test (TCAO-test), an indirect contact in vitro cytotoxicity assay, has been validated and made available for practical applications concerning medical device safety testing. This assay fits in the test matrix as presented by the International Organisation for Standardisation (ISO) and will be adopted in the European Biocompatibility testing scheme of CEN (Comite Europeen de Normalisation). Forthcoming Notified Bodies may apply this TCAO-test complying with the essential requirements of the Active Implantable Medical Device Directive. The detailed testprotocol is described and testresults are presented.